KR101518147B1 - Material removal device and method of use - Google Patents

Abstract

The posteroanterior resection catheter 2 has an inner drive shaft 6 that rotates a distal rotating tissue perforator 7 with a helical cutting face that allows the catheter to cut through and cross the CTO. The porcine resection catheter is also rotated by the outer drive shaft 3 and has a distal cutting element 4 configured to cut material from the vessel wall of the treatment site when the catheter is pushed in a distal direction through the treatment site. The porphyseal resection catheter includes a collection chamber (12) disposed proximal to a cutting element and a rotating tissue perforator. The porcine resection catheter includes means for guiding the excised material from the treatment site to the collection chamber, means for grinding most of the material capable of blocking or occluding the collection chamber, and means for grinding the collected material from the treatment site to a porcine resection catheter To the proximal opening of the proximal opening.

Description

[0001] MATERIAL REMOVAL DEVICE AND METHOD OF USE [0002]

This application claims priority to U.S. Provisional Patent Application No. 61 / 407,788, filed October 28, 2010, entitled " Material Removal Device and Method of Use ", the contents of which are incorporated herein by reference .

The present invention relates to a catheter used for removing and collecting material from a treatment site in a body cavity. More particularly, the present invention relates to atherectomy catheter having a dual drive shaft capable of traversing a completely occluded treatment site in a vessel to enable the catheter to effectively treat the vessel at the treatment site.

Atherosclerosis is a progressive vascular disease in which atheroma is deposited in the lining of the blood vessel. Atherosclerosis is a complex, progressive, and degenerative disease that results in accumulation of other occlusive substances known as cholesterol and plaques on the walls of the arteries. Accumulation of the plaque reduces blood flow by narrowing the internal or internal lumen of the artery.

Plaques occur in various forms within the arteries and can be located within various anatomical structures throughout the arterial system. The plaques are different in the composition of the hard and brittle parts, called calcified plagues, and the fatty or fibrous parts. Over time, atheroma deposits may become large enough to reduce or obstruct blood flow through the blood vessels, which may include pain of the legs (walking or resting), skin ulcers, Other symptoms include low blood flow symptoms. In order to treat this disease and to ameliorate or alleviate these symptoms, it is desirable to restore or improve blood flow through the blood vessels.

Various means have been used to restore or improve blood flow through the periosteal blood vessels. The atheroma deposits can be removed by expanding the vessel diametrically with balloon dilatation, stent expansion and other methods. Such scar tissue (restenosis material), once formed, blocks flow in the blood vessel and is often required to be removed. Deposits can be pulverized using lasers and other methods, but pulverization of the athermal material only allows the microemboli to flow downstream and stay in peripheral blood vessels, which may further impair blood flow to tissues affected by the disease have. Porcine resection catheters can be used to remove atheroma deposits from blood vessels and can provide an ideal solution when atheroma debris removed from blood vessels is captured and removed from the body.

Catheters with rotating burrs, lasers that photo-dissolve tissue, and catheters using balloons or other positioning devices to position the cutter adjacent to the material to be removed , A number of porphyseal resection catheters have been proposed.

In addition, some catheters have a collection chamber disposed on a circle in the cutting window. To this end, the length of the distal catheter of the cutting window should be long enough to accommodate the collection chamber. This causes some design choices to conflict. On the other hand, it is desirable for the collection chamber to have a capacity large enough to accommodate a significant amount of cut material before the chamber is filled and the catheter has to be removed. On the other hand, increasing the distal catheter length of the cutting window, which is necessary to accommodate a sufficiently large collection chamber, is disadvantageous in certain applications. For example, if the treatment site or lesion is located in a blood vessel having a particularly serpentine anatomy or a small size, the vessel space accessible to the distal side of the lesion may not be sufficient to accommodate the distal catheter end length of the cutting window have. The area accessible to the distal side of the treatment site is often referred to as a "landing zone ". For efficient use of the catheter, the catheter must be anatomically structured so that the catheter can be advanced far enough so that the cutting window is positioned within the treatment site and that the distal end of the catheter is positioned in the landing zone. Thus, a catheter in which the collection chamber is placed on the circle of the cutting window may be difficult to use in short blood vessels in the landing zone.

U.S. Provisional Patent Application Serial No. 61 / 354,487, filed June 14, 2010, which is incorporated herein by reference in its entirety, discloses a catheter resection catheter that solves some of these problems have. The catheter has a rotating end tip with a polishing surface that allows the catheter to cut through and cross the CTO. The catheter includes a side cutting window and a cutting blade configured to extend through the cutting window and cut material from the vessel wall of the treatment site when the catheter is pulled proximally through the treatment site. The catheter includes a substance collection chamber disposed on the proximal side of the cutting window. During use, the rotating abrasive tip allows the catheter to traverse the treatment site, even in the case of a CTO. The cutting window is advanced distally to the treatment site, the cutting blade extends out of the cutting window, and the material is cut from the treatment site by pulling the catheter toward the proximal side across the treatment site. Because the material collection chamber is positioned on the proximal side of the cutting window, the length of the distal catheter relative to the cutting window is reduced to allow the catheter to cure lesions with short landings.

Although this catheter has features that overcome some of the aforementioned problems, it can be used to access lesions of the vasculature, such as when the lesion is in a difficult position to treat with a catheter of the prior art, or when the vessel is completely occluded at the treatment site There is still a need for a porcine resection catheter that can be used to do this. There is also a need for a pterygium resection catheter configured to effectively carry fragments that have been severed from a truncated position to a storage location, even when the storage location is spaced proximal from the truncated position.

Porcine resection catheters having features that overcome the problems faced by prior art devices are disclosed herein. Hereinafter, the salient features that may be included in these catheters will be described. The catheters may include one or more of these features, either individually or in combination, and the catheters are not intended to be limited to the specific embodiments disclosed herein. In one embodiment, a porcine resection catheter has an inner drive shaft that rotates a distal rotating tissue perforator having a helical cutting face that allows the catheter to cut through and cross the CTO. The porcine resection catheter is also rotated by the outer drive shaft and has a distal cutting element configured to cut material from the vessel wall of the treatment site when the catheter is pushed in a distal direction through the treatment site. The inner and outer drive shafts can rotate in the same direction (co-rotation) or in the opposite direction (reverse rotation). The catheter includes a cutting chamber and a collection chamber disposed on the proximal side of the rotating tissue puncture machine. The catheter may include means for guiding the material cut from the treatment site into the collection chamber. The catheter of the present invention may be optionally configured to include means for comminuting most of the material that is capable of blocking or occluding the collection chamber and the associated passageway and may be configured to deliver the collected material from the treatment site to the proximal opening of the porcine resection catheter And means for conveying the image.

In one variant, the catheter is a material removal device for cutting a material from the lumen of a blood vessel, the material removal device comprising: a tubular sheath having distal and proximal ends and a lumen; A first drive shaft extending through the lumen of the tubular sheath and configured to rotate in a first direction; A second drive shaft extending through the lumen of the tubular sheath and configured to rotate in a second direction; A first cutting element coupled to the first drive shaft; A second cutting element coupled to the second drive shaft; And a driver coupled to the first and second drive shafts and configured to rotate the first drive shaft in the first direction and rotate the second drive shaft in the second direction. Wherein the driver includes a single drive element coupled to both the first and second drive shafts, or a second drive element coupled to the first drive shaft and a second drive coupled to the second drive shaft, Elements may optionally be included. The first rotation direction may be opposite or the same as the second rotation direction. The first drive shaft may rotate at a first rotational speed, and the second drive shaft may rotate at a second rotational speed. The first and second rotational speeds may be the same or different. The first drive shaft may be tubular and may include an inner surface forming a lumen. The second drive shaft may be at least partially received within the lumen of the first drive shaft. Optionally, a material receiving chamber is formed between an outer surface of the second drive shaft and an inner surface of the first drive shaft. Optionally, at least one of the outer surface of the second drive shaft and the inner surface of the first drive shaft includes at least one raised mass transfer element, such as a rib, wherein the at least one raised mass transfer element And to move the cut material from the lumen in the proximal direction. The at least one raised material transfer element may be arranged in a spiral pattern. Optionally, the first and second cutting elements may have a first state in which the first and second cutting elements are received within the lumen of the tubular sheath and a first state in which the first and second shearing elements are located at the distal end of the tubular sheath Lt; RTI ID = 0.0 > least < / RTI > partially exposed.

In another variation, a catheter, which may include some or all of the features described above, is used to cut the material from the lumen of the vessel at the vessel site. The method further comprises advancing the tubular sheath through the lumen of the vessel to a position proximate to the vessel site; Rotating the first drive shaft in a first direction within the lumen of the tubular sheath; Rotating the second drive shaft in the lumen of the tubular sheath in a second direction; And advancing the tubular sheath in a distal direction through the lumen of the vessel across the vascular site while rotating the first and second drive shafts to cut the material into the first and second cutting elements . The first and second directions may be the same or different. The first drive shaft can rotate at a first speed and the second drive shaft can rotate at a second speed and the first speed is equal to or different from the second speed. The first drive shaft may be tubular and may include an inner surface forming a lumen, the second drive shaft may be at least partially received within the lumen of the first drive shaft, And rotates in the lumen of the drive shaft. The second drive shaft may include an outer surface and a material receiving chamber is formed between an outer surface of the second drive shaft and an inner surface of the first drive shaft, ≪ / RTI > Wherein at least one of the outer surface of the second drive shaft and the inner surface of the first drive shaft includes at least one raised material transfer element, the at least one raised material transfer element is configured to move the material cut from the lumen of the vessel in a proximal direction Wherein conveying the cut material proximally to the material receiving chamber comprises rotating at least one of the first and second drive shafts.

Other aspects of the invention will become apparent from the following description of the preferred embodiments, drawings and claims. The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a partial side cross-sectional view of a porcine resection catheter and inner and outer cutter actuators.
2 is a cross-sectional perspective view of the distal end of a porcine resection catheter of the present invention.
3 is a side cross-sectional view of the distal end of a porcine resection catheter of the present invention.
4 is a perspective view of a distal cutting element of a porphyseal resection catheter of the present invention.
5-7 are side cross-sectional views of another embodiment of an outer cutter drive shaft of a porcine resection catheter of the present invention.
Figure 8 is a perspective view of a rotating tissue punch of a porcine resection catheter of the present invention.
9-11 are side views of the inner cutter drive shaft of a porcine resection catheter of the present invention.
12 is a side cross-sectional perspective view of the tissue chamber of a porcine resection catheter of the present invention.
Figures 13 and 14 are distal end views showing the alignment and misalignment of the cutter element flutes and perforator flutes of a porcine resection catheter of the present invention, respectively.
15 and 16 are a cross-sectional perspective view and an end view, respectively, of an alternate embodiment of the porphyseal resection catheter of the present invention.
17 and 18 are a cross-sectional perspective view and an end view, respectively, of an alternate embodiment of the porphyseal resection catheter of the present invention.
FIGS. 19A, 19B and 19C are views showing a method of using a porcine resection catheter.
20-22 are a cross-sectional perspective view, a side view, and a distal end view, respectively, of an alternate embodiment of a porcine resection catheter of the present invention.
23 to 25 are a cross-sectional perspective view, a side view, and an end view, respectively, of an alternate embodiment of a porcine resection catheter of the present invention.

A catheter having a catheter body adapted to be introduced into a body cavity relative to a target body cavity is disclosed herein. The dimensions and other physical characteristics of the catheter body can vary greatly depending on the body cavity to be accessed. In the exemplary case of a porphyseal resection catheter intended for intravascular introduction, the distal portions of the catheter body will typically be very flexible and suitable for introduction onto the guide wire to the target site in the vasculature. In particular, the catheter can be made for "over-the-wire" introduction when the guide wire channel completely extends through the catheter body, and the guide wire channel extends only through the distal portion of the catheter body Can be made for the introduction of "swift exchange". In other cases, it is possible to provide a coil tip or guide wire tip that is fixed or integral with the distal portion of the catheter, or even the entire guide wire may be omitted. For convenience of illustration, it should be understood that although not shown in all of the embodiments, the guide wire may be included in any of the embodiments disclosed herein as being configured for use with the guide wire.

The intracorporeal catheter body will typically have a length in the range of 50 cm to 200 cm and an outer diameter of 1 French to 12 French (0.33 mm: 1 French), typically 3 French to 9 French. For coronary artery catheters, the length is typically in the range of 125 cm to 200 cm, and the diameter is preferably less than 8 French, more preferably less than 7 French, and most preferably 2 French to 7 French. The catheter body will typically consist of organic polymers made by conventional extrusion techniques. Suitable polymers include polyvinyl chloride, polyurethane, polyester, polytetrafluoroethylene (PTFE), polyamide, silicone rubber, natural rubber and the like. Optionally, the catheter body may be reinforced with braids, spiral wires, coils, axial filaments, etc. to increase rotational strength, column strength, toughness, pushability, kink resistance and the like. A suitable catheter body may be formed by extrusion, optionally with one or more channels. The catheter diameter can be modified by thermal expansion and contraction using conventional techniques. Thus, the catheter thus manufactured will be suitable for introduction into the vasculature including both the coronary artery and the peripheral artery by the conventional technique.

Figures 1 to 14 illustrate a porcine resection catheter 2 including various optional features. As best seen in FIG. 1, which is a partial side cross-sectional view, the catheter 2 has an introduction sheath 5, which is the outermost layer or layer and an exposed layer of the catheter exposed to the vessel wall. The introduction sheath 5 may be made of an organic polymer and serves to assist the movement of the catheter 2 through the anatomy of the blood vessel. The envelope 5 may be stationary or it may be configured to move longitudinally over the distal tip surrounding the cutting tip for delivery or removal of the catheter. In use, the envelope 5 may be retracted to expose the cutter. When the rotary cutter is activated, the sheath 5 does not rotate to protect the vascular structure from the rotational movement of the rotating outer cutter drive shaft 3. 2 and 3, which are a cross-sectional perspective view and a side view, respectively, of the distal end of the catheter 2, an outer cutter drive shaft 3 (not shown) connected to rotate the cutting element 4 at the distal end of the catheter, Is disposed adjacent to and directly below the introduction sheath. The outer cutter drive shaft 3 may be composed of a high modulus material or composite, such as a NiTi tube, a stainless steel coil or other layered polymer composite or metal material with flexibility and torqueability. A suitable clearance is provided between the outer sheath 5 and the outer cutter drive shaft so that a slip fit is achieved in which free rotation is achieved between the sheath and the outer cutter drive shaft. Either or both of the shaft 3 and the sheath 5 may be coated with a lubricating coating to reduce friction therebetween. An inner cutter drive shaft 6 is disposed at the center of the lumen 21 of the outer cutter drive shaft 3. The inner cutter drive shaft 6 may be composed of a high Young's modulus material or composite, such as a NiTi tube, a stainless steel coil or other layered polymer composite or metal material, having flexibility and torque. The inner cutter drive shaft 6 serves to rotate a second cutting element, more specifically a rotating tissue perforator 7 attached to the distal end of the drive shaft 6.

The distal cutting element 4 is shown in detail in FIG. The distal cutting element 4 is attached to the outer cutter drive shaft 3 by welding, brazing, adhesive or the like. The distal cutting element 4 is used to cut the material from the lumen of the bloodstream, such as an artery or vein, and to transport the tissue material collected from the distal tip of the catheter to the proximal opening side, as described in greater detail below. The catheter 2 comprises a rotating tissue puncturer 7 (second cutting element of the two cutting elements) attached to the inner cutter drive shaft 6 by welding, brazing, adhesive or the like. The rotating tissue perforator 7 can be used to puncture occlusions in the lumen that may interfere with the distal movement of the catheter through the blood vessels and can be used to puncture the tissue material collected from the distal tip of the catheter through the distal opening or flute, (9), which will be described in more detail below.

The proximal end of the outer cutter drive shaft 3 of the catheter 2 is coupled to the outer cutter driver 10 which is connected to the outer drive shaft 3 and also to the attached distal cutting element 4, . An inner cutter drive shaft 6 extending through the lumen 21 of the outer cutter drive shaft 3 has its proximal end coupled to the inner cutter driver 11 and the inner cutter driver is coupled to the inner drive shaft 6, And also rotates the attached rotating tissue perforator 7. The outer cutter driver 10 and the inner cutter driver 11 individually drive and rotate the outer cutter drive shaft and the inner cutter drive shaft so that each drive shaft can rotate clockwise or counterclockwise. In one embodiment, the catheter 2 can be used with both the inner cutter drive shaft 6 and the outer cutter drive shaft 3 rotated either clockwise or counterclockwise. In another embodiment, one of the inner and outer cutter drive shafts can rotate clockwise, and the other one of the inner and outer cutter drive shafts can rotate counterclockwise. The inner and outer cutter drive shafts can rotate at the same speed or at different speeds as described in more detail below. Those skilled in the art will understand that, although not shown, a single drive motor can be used to rotate both the inner cutter drive shaft and the outer cutter drive shaft, by using an appropriate gear device .

The catheter (2) includes a tissue collection chamber (12). The tissue collection chamber 12 includes an annular space between the inner surface of the outer cutter drive shaft and the outer surface of the inner cutter drive shaft, As shown in Fig. The catheter 2 includes a proximal opening (not shown) with a tube attached thereto for facilitating the aspiration of cutting debris or the injection of fluid (including drugs) through the annular space between the outer cutter drive shaft 3 and the inner cutter drive shaft 6 (9).

The outer cutter driver 10 and the inner cutter driver 11 are substantially similar and may include any suitable drive motor and power source (e.g., one or more batteries) known in the art. The cutter actuators 10, 11 are incorporated into a handle that can be attached to the proximal end of the catheter. The handle may include one or more levers or switches for controlling the motor. In one embodiment, both cutter actuators may be switched together to rotate in the opposite direction. Alternatively, each driver may have a control switch such that each driver can be activated independently of each other. Accordingly, any one of the cutters can be rotated independently of the other cutters, and rotated at different speeds or directions. This is advantageous in a situation where, for example, the outer cutter is kept stationary and only the inner cutter is intended to rotate, in order to transport tissue through the tissue collection chamber 12 without further cutting to the outer cutting element 4, for example. Also, after crossing the CTO, it is advantageous to retract the inner cutter and continue cutting with the outer cutter. Thus, the inner cutter drive shaft may be longitudinally movable relative to the outer cutter drive shaft. The longitudinal advancement or retraction of the inner cutter drive shaft is controlled by the control lever of the handle. In another embodiment, one switch is used to simultaneously activate both cutter drivers. The control handle may be provided with a controller that allows the operator to control the direction of rotation of each cutter.

The distal cutting element 4 rotates about the longitudinal axis LA of the catheter 2 as the outer cutter drive shaft 3 rotates. The distal cutting element 4 may rotate at about 1 to 160,000 rpm, but may rotate at any other suitable speed depending on the particular application. The cutting element 4 may be formed of one continuous part or may be composed of several parts which are subsequently joined together by welding, brazing, brazing, adhesive bonding, mechanical fitting or other means. The cutting element 4 may be formed of any suitable material capable of maintaining abrasion resistance of the cutting edge, such as hardened steel, carbide or Ti-nitride coated steel. 4, the distal cutting element 4 includes a cup-shaped surface (not shown) that guides the tissue cut by the cutting edge 22 into the tissue chamber 12 through the opening or cutting element flutes 23 24). The cutting element 4 comprises a distal cutting edge 22 disposed at the radially outer circumferential edge of the distal cutting element 4. In use, when cutting element 4 rotates, cutting edge 22 creates a generally circular cut in the material to be removed. The cup-shaped surface 24 induces the cutting material radially inward.

The flute 23, in cooperation with the rotation of the spiral groove 35 of the rotating tissue perforator 7, acts to crush the material. The flute has a semicylindrical shape oriented generally parallel to the longitudinal axis of the catheter (alternatively, the flute may be oriented at an angle relative to the longitudinal axis) and has a diameter of 0.001 to 0.030 inches, more typically 0.008 to 0.010 inches And has a length of 1 to 10 mm, more typically 4 to 6 mm. The size of the flute is selected to allow sufficient space for the cutting material to enter the annular collection chamber disposed between the inner and outer cutter drive shafts.

The force applied to the catheter against the lesion facilitates entry of the cleaving material through the openings into the catheter during use. The cutting element 4 comprises an inner surface which is substantially cylindrical, the inner surface of which is reduced in diameter at the perforator ledge 25. A proximal oriented annular surface that lies within a plane generally perpendicular to the longitudinal axis of the catheter connects the reduced diameter diameter perforator ledge 25 to a larger diameter portion of the inner surface. The ledge 25 is slightly larger than the inner circumference of the rotating tissue perforator 7 but has a smaller inner circumference than the circumference of the outer cutter drive shaft and serves as a supporting surface that allows rotation of the rotating tissue perforator 7, Function. This prevents the rotating tissue perforator 7 from extending beyond the distal end of the catheter 2 beyond a desired distance. The outer cutter drive shaft may be connected to the proximal portion 26 of the distal cutting element by welding, brazing, brazing or adhesive bonding.

A side cross-sectional view of various embodiments of the outer cutter drive shaft 3 is shown in Figs. 5-7. 5, the outer cutter drive shaft 3 has a push-down shear 28, and the push-down shear has a groove on its surface when the outer cutter drive shaft is formed, And then pressed toward the inner diameter of the outer cutter drive shaft. The shears are formed by laser cutting or mechanically cutting the partial contour of the shear profile inside the outer cutter drive shaft. After being cut, the shears are pushed inward. The push-down shears 28 are discontinuous and may follow a helical winding pattern that may be spaced apart at any distance from each other, depending on the application. Shear members 28 are provided on at least a portion or all of the outer cutter drive shaft 3 between the handle and the cutters. Further, a laminate such as a polyester heat shrinkable body can be added to the outer surface of the drive shaft 3 to produce a watertight / hermetic seal.

In another embodiment, as shown in Fig. 6, the outer cutter drive shaft 3a has a push-down discontinuous spiral rib 29 formed substantially similar to the push-down shear 28. The contour of the helical rib 29 is pressed toward the inner diameter of the next outer cutter drive shaft which is formed with grooves on the outer surface thereof when the outer cutter drive shaft is formed. The helical ribs 29 are formed such that each discontinuous portion of the ribs is spaced apart from the adjacent portions by a sufficient distance to ensure structural circularity of the drive shaft. The discontinuous portions are provided on at least a portion or all of the drive shaft, and may follow a helical winding pattern. In addition, a laminate, such as a polyester heat shrink tube, may be added to the drive shaft 3 to create a watertight / hermetic seal.

In another embodiment, as shown in Fig. 7, the outer cutter drive shaft 3b has a spiral rib 30, which is continuous and follows a helical winding pattern for at least a portion or all of the outer drive shaft. The spiral ribs (30) are formed in the inner diameter of the outer cutter drive shaft (3). The helical ribs can be formed by attaching a tube to the inner surface of the outer cutter drive shaft 3, said tube having a spiral attached to the inner wall of the tube, or said tube being a shaped tube with an inner thread. The spiral ribs 30 of the outer cutter drive shaft may be discontinuously formed as in the push-down shear 28 according to the application, or may be formed as separate continuous spiral wound patterns 28 spaced a predetermined distance below the length of the tissue chamber And the like. Shear 28 and helical ribs 29 and 30 may guide tissue toward the proximal opening 9 and may break up most of the thrombus or collected tissue material that may be formed. The outer cutter drive shaft may be made of any suitable material with sufficient flexibility. It should be noted that the outer cutter drive shaft may be formed without a shear or spiral rib according to the application, or both. In addition, the shear and slope of the spiral pattern of the ribs may be selected according to the particular application in which the catheter is used. It is also contemplated that the outer cutter drive shaft 3 (or the outer cutter drive shaft of any of the other embodiments disclosed herein) may reduce the augmentation / tissue adhesion to the lubricant or outer cutter drive shaft, such as Teflon Such as heparin or urokinase, to prevent blood clotting in the tissue collection chamber 12, as well as other coatings for use in the tissue collection chamber 12.

The rotating tissue perforator 7 rotates about the longitudinal axis LA of the catheter as the inner cutter drive shaft 6 rotates. The rotating tissue perforator 7 rotates at about 1 to 160,000 rpm, but may rotate at any other suitable speed depending on the particular application. The rotating tissue perforator may be formed of a single continuous portion or may be composed of several portions that are subsequently joined together by welding, brazing, brazing, adhesive bonding, mechanical fitting or other means. 8, the rotating tissue perforator 7 has a distal portion 34, which can be formed with a helical cutting surface 35, and an occlusion in the lumen is punctured to be cut by a tissue puncturer The tissue can be directed into the tissue chamber 12 through the opening or perforator flute 31 (and the cutter element flute 23). The tissue perforator 7 is sized to fit within the distal cutting element 4. More specifically, the tissue perforator 7 includes a bushing 32 at the proximal end of the distal portion 34. The bushing 32 has a circumferential outer surface larger than the distal portion 34 of the rotating tissue perforator 7 but smaller than the circumferential inner surface of the ledge 25 of the outer cutter drive shaft 3. The bushing 32 includes a circumferentially oriented annular surface sized to abut an annular surface oriented in the proximal direction of the ledge 25 and is configured to permit rotation while limiting the distal movement of the rotating tissue perforator 7 As a bearing. The perforator flute 31 extends from the proximal portion 36 to the distal portion 34. The flute (31) and flute (23) have a shape that allows the cut debris to move in a proximal direction to the collection chamber. For example, the flute 31 may have a semi-cylindrical cross-sectional shape along the distal and proximal surfaces, and may have a cylindrical shape when extending through the bushing 32. The diameter of the flute 31 may be the same as that of the flute 23. The flute 31 provides dual function. First, they serve to shear the material cut by the cutting edges of the tissue punch and outer cutter with the flute 23, and second, they allow the cut material to pass through the distal end of the catheter, Allowing it to move into the chamber. The proximal portion 36 may receive the distal end of the inner cutter drive shaft 6 as shown in Figures 2 and 3 and may be attached by welding, brazing, brazing, or adhesive bonding.

The form of various embodiments of the inner cutter drive shaft 6 is shown separate from the rest of the catheter 2 in Figures 9-11. The inner cutter drive shaft 6 may be made of any suitable material with sufficient flexibility and may be substantially solid or hollow, depending on the application. Suitable materials include high-k materials or composites with flexibility and torque, such as NiTi tubes, stainless steel coils or other layered polymer composites or metallic materials. In some applications in which the inner cutter drive shaft is hollow, the guide wire lumen 37 may extend along the length of the inner cutter drive shaft. The inner cutter drive shaft can be made of helically wound stainless steel wire that can be wound in the left or right hand direction and has welded proximal and distal ends that do not exceed the outside dimensions of the wound wire. The inner cutter drive shaft can be made of twisted steel wire. In some embodiments, the inner cutter drive shaft may be comprised of multiple layers of spirally wound wires. In some cases, adjacent layers of spirally wound wires are wound in opposite directions.

A partial view of the inner cutter drive shaft 6 is shown in Fig. In Fig. 9, the inner cutter drive shaft is oriented so that the proximal and distal ends (not shown) of the drive shaft lie on the left and right sides of Fig. 9, respectively. The inner cutter drive shaft 6 is formed of a left-handed spiral winding portion 38 continuous with at least a part or the whole of the drive shaft as desired. The spiral may be wound in the left-hand direction winding pattern as shown in Fig. 9, or may have the right-hand direction spiral winding pattern as shown in Figs. In either case, the helix will be rotated in one direction to draw the substance proximal. When the inner cutter drive shaft 6 rotates counterclockwise, the helical winding 38 rotates and collects through the cutter element flute 23 and the perforator flute 31 at the distal end of the catheter 2, The cut material is directed towards the proximal opening 9 (from left to right in FIG. 9). It should also be noted that when both the inner and outer cutter drive shafts rotate in the opposite direction, the spiral wound portion 38 of the inner drive shaft 6 and the shear 28 of the outer drive shaft, Most of the blood clots and collected tissue that can be formed by physical force and compressive force are crushed. Of course, as will be described in greater detail below, the inner and outer cutter drive shafts may either reverse at the same or different speeds, or rotate in the same direction at the same or different speeds.

The inner cutter drive shaft 6a of Fig. 10 is formed with a helical channel 18. The spiral channel 18 may be formed on the solid or hollow shaft surface by laser or mechanical cutting. This process results in the formation of a helical rib between the channels 18 that functions in a manner similar to the drive shaft 6 of Fig.

The inner cutter drive shaft 6b of Fig. 11 combines the features of both drive shafts 6, 6a. The drive shaft 6b is formed as a portion having a helical winding portion 38 and a portion having a helical channel 18. [ The spiral wound portion of the inner cutter drive shaft may be manufactured discontinuously, such as in the shape and spacing of the push-down shear 28 of the outer cutter drive shaft, depending on the application, or separately ≪ / RTI > of continuous spiral winding patterns. The spiral wound portions 38 and the helical channel 18 can guide tissue toward the proximal opening 9 and can crush most of the thrombus or collected tissue material that may be formed. The inner cutter drive shaft may be made of any suitable material with sufficient flexibility. The inner cutter drive shaft may be formed without spiral winding or spiral channels according to the application, or it may be formed by a combination of the two, and the helical pattern of the shears and ribs may be linear or any suitable pattern . It is also contemplated that the inner cutter drive shaft 6 (or the inner cutter drive shaft of any of the other embodiments disclosed herein) may be a lubricant, such as Teflon, or other It should be noted that it may additionally be coated with a coating or with an anticoagulant or thrombolytic agent coating such as heparin or urokinase to prevent blood clotting in the tissue collection chamber 12.

In an exemplary use of the catheter, the catheter may be placed in the blood vessel until the distal end of the catheter 2, along with the distal cutting element 4 and the rotating tissue puncturer 7, is adjacent or very close to the proximal end of the treatment site of the vessel . When the distal cutting element 4 and the rotating tissue perforator 7 move to the appropriate longitudinal position in the blood vessel, the outer cutter driver 10 causes the outer cutter drive shaft and the distal cutting element to rotate counterclockwise. The inner cutter driver 11 also rotates the inner cutter drive shaft and the rotating tissue perforator in a clockwise direction. While the rotation of the inner drive shaft is a counterclockwise rotation, the outer cutter drive shaft may rotate clockwise, or both of the cutter drive shafts may rotate clockwise or counterclockwise according to the orientation of the spiral ribs . The orientation and rotational orientation of the helical ribs (left hand or right hand) will be selected so that the cutting material is finally transported through the catheter in a proximal direction from the distal end to the proximal end of the catheter. This can be realized if both the inner and outer cutter drive shafts are designed to propel the material in the proximal direction. This also means that one of the inner and outer cutter drive shafts is designed to move the material in the proximal direction and the other is designed to move the material or fluid in a distal direction, As long as it provides a large propulsive force, i.e., a larger transmission speed. For example, the inner cutter drive shaft has an orientation and rotational direction of a spiral rib that moves material in a proximal direction, while an outer cutter drive shaft has an orientation and rotation direction of a rib or shear that tends to propel material in a distal direction Lt; / RTI > As long as the propulsive force provided by the inner cutter drive shaft (provided by a larger take-up pitch with a higher rotational speed or greater mass capacity) is greater than the propulsive force provided by the outer cutter drive shaft, Will be in the proximal direction. Alternatively, the outer cutter drive shaft has an orientation and rotation direction of the rib or shear that moves the material in the proximal direction, while the inner cutter drive shaft has an orientation of the helical rib that tends to propel the material or fluid in the distal direction Lt; / RTI > As long as the propulsive force provided by the outer cutter drive shaft is greater than the propulsive force provided by the inner cutter drive shaft, the direction of movement of the substance through the catheter will be proximal. In these embodiments, opposing propulsive forces may act to further crush the material to facilitate transport of the material. It should also be noted that, depending on the application, one of the cutter drive shafts may be rotating while the other may be stationary. It should also be noted that the two cutter drive shafts, the distal cutting elements attached thereto, and the rotating tissue perforator may rotate at the same or different speeds depending on the application.

After the cutter actuators or actuators are activated, the catheter 2 is pushed in the distal direction through the blood vessel with the distal cutting element 4 and the rotating tissue perforator 7 in a rotational or cut position as will be described in more detail below . It should be noted that, in some applications, only the rotating tissue perforator 7 may be rotated to safely puncture the entire occlusion. The tissue material cut by the distal cutting element 4 and the rotating tissue puncturer 7 is guided by the cup-shaped surface 24 to the cutter element flutes 23 and 24 when the catheter 2 moves distally through the blood vessel. Is guided into the perforator flute (31) and transferred to the tissue collection chamber (12) located adjacent to the distal cutting element (4) and the rotating tissue perforator (7). As can be seen in Figure 12, the tissue collection chamber 12 includes an outer cutter drive shaft having a spiral rib 30 following a continuous spiral right-hand winding pattern through a chamber, a continuous spiral, And an inner cutter drive shaft 6 having a helical winding portion 38 following the winding pattern. When the inner cutter drive shaft 6 is engaged, the rotation of the spiral take-up 38 creates a force which forces the tissue collected in the tissue collection chamber to be proximal when the drive shaft 6 rotates counterclockwise Can be guided toward the opening (9). Additionally or alternatively, rotation of the helical ribs 30 when the outer cutter drive shaft is engaged can produce a force that is collected in the tissue collection chamber as the outer cutter drive shaft rotates clockwise The tissue can also be directed towards the proximal opening. The spiral rib and the left or right winding orientation of the spiral wound section can aid in the direction of flow of material through the tissue chamber in combination with clockwise or counterclockwise rotation of the inner and outer cutter drive shafts, . It should be noted that the slope, size, left or right winding patterns of the spiral winding section, spiral channel, spiral rib and shear sections of the present invention can be varied both in accordance with the application example and the desired material transfer rate.

Figures 13 and 14 show distal end views of the catheter 2. In Figure 13, the cutter element flutes 23 of the distal cutting element 4 and the perforator flutes 31 of the rotating tissue perforator 7 are aligned to create a circular chute or pathway through which the lumen The cut material may pass through to enter the annular collection chamber. Figure 14 shows that when the distal cutting element 4 and the rotating tissue perforator 7 rotate in opposite directions (or simultaneously rotate at different speeds), the collected material is transferred to the perforator flute 31 by successively offsetting and re- And the cutter element flute 23, as shown in Fig. It should be noted that when the perforator flute and the cutter element flutes are offset and rearranged, the shearing of tissue may occur as the rotating tissue perforator and distal cutting element are rotated in the same direction all at different rates. This shearing effect created by the opposite rotation of the tissue puncture and cutting elements allows the collected tissue to more easily pass through the flutes and into the tissue collection chamber.

The tissue is sheared into tissue collection chamber 12 through the distal cutting element and the flutes of the rotating tissue punch. The material collection chamber extends to receive the cut material and can be as long as the length of the catheter. The proximal portion of the catheter body may additionally have a proximal opening 9 so that tissue transported through the catheter can escape through the opening or sidewall port. The length of the tissue collection chamber is not limited by the size of the landing zone of the treatment site, and the tissue collection chamber can be made to have any desired length, since the tissue collection chamber is disposed adjacent the cutting element and the tissue perforator. When the inner cutter drive shaft 6 is engaged, rotation of the helical winding 38 or helical channel 18 produces a force which is collected in the tissue collection chamber in accordance with the direction of rotation of the helical winding or helical channel And the proximal opening 9 can be guided in the proximal direction. Additionally or alternatively, rotation of the push-down shear 28 (or the spiral ribs 29 and 30) when the outer cutter drive shaft is engaged produces a centripetal force which is transmitted to the push- (Or spiral ribs 29 and 30) in the inward direction toward the inner drive shaft 6a. The force generated by the rotational motion and momentum of the helical winding on the inner cutter drive shaft causes a force generated by the rotational motion and momentum of the push-down shear 28 of the outer cutter drive shaft 3, Causing breaks and thrombosis to further break down and cause degradation. These forces of the helical winding and / or push-down shear may also produce a suction force through the cutter element flutes 23 of the distal cutting element 4 and the perforator flutes 31 of the rotating tissue perforator 7 , This attractive force aids in the passage of the substance through the flutes. It should be noted that, in some applications, additional suction may be applied as desired through the proximal opening 9 to assist in the collection of material.

In another use, the catheter 2 cuts the softer atheroma from the vessel wall into relatively large strips and, in some applications with the rotating tissue perforator 7, the cup-shaped surface 4 of the distal cutting element 4 (24) direct these strips to the collection chamber (12) through the cutter element flutes (23) and the perforator flutes (31). Since the collection chamber 12 is positioned adjacent to both the distal cutting element 4 and the rotating tissue perforator, the cutter element flutes 12 are arranged so that there are no obstacles as possible, such as tissue strips that are too large to pass through the tissue punch and flutes of the cutting element. (23) and the perforator flute (31). The opposite rotation of the rotating tissue perforator 7 and the distal cutting element 4, or in other embodiments the same rotational speed in the same rotational direction, may be achieved by aligning the cutter element flutes 23 and the perforator flutes 31, , Which shear force helps break up large strips of tissue and facilitates the transport of tissue through the flutes to the tissue collection chamber.

It is more desirable to maintain the tissue collection chamber so that there is as little obstruction as possible to allow for the proximal movement of tissue collected toward the proximal opening 9. [ Another potential obstacle may arise when the tissue collected in the tissue collection chamber is clotted or occluded, which interferes with the movement of the cutting material from the collection chamber toward the proximal opening. As described above, the forces generated by the rotational motion and momentum of the helical winding section, the helical ribs, the spiral channel, and the push-down shear windings are caused by the rotation of the push-down shear 28 of the outer cutter drive shaft 3 Causing the occlusion and thrombosis to be broken into smaller fragments in response to shear forces generated by motion and momentum. The rotation of the outer cutter drive shaft and the inner cutter drive shaft may be in the opposite direction or in the same direction, depending on the application. It may be desirable to maintain the collected tissue constantly advanced within the tissue collection chamber from the distal end of the catheter toward the proximal opening. As described above, when the inner cutter drive shaft 6 is engaged, the rotation of the spiral take-up 38 generates a force which, in accordance with the direction of rotation of the spiral take-up, Can be guided toward the opening (9). Additionally or alternatively, rotation of the push-down shear 28 when the outer cutter drive shaft is engaged produces a centripetal force that is collected in the tissue collection chamber in accordance with the direction of rotation of the push- Or may direct the tissue to the proximal opening. In some applications, both the inner cutter drive shaft and the outer cutter drive shaft are equally rotatable in the proximal direction. In other applications, the inner cutter drive shaft and the outer cutter drive shaft may rotate in opposite directions. In applications where forces generated by one of the drive shafts deliver a substance or fluid in a distal direction and forces generated by the other one of the drive shafts deliver the substance in a proximal direction, The rotational speed, the rib size, and / or the ribs or the push-down ratio of the drive shaft that transfer material in the proximal direction to overcome the forces in opposing directions produced by other drive shafts, The pitch of the short periods may be greater than the rotational speed of the drive shaft, the rib size, and / or the pitch of the ribs or push-down shear units that convey the material in the distal direction. Thus, the drive shaft must be designed and operated in such a way as to produce a net force that transfers the substance in the proximal direction. The rib size, the clearance between the shear units and the drive shaft, the pitch, the relative rotational speed between the rotating shafts, and the surface finish or friction coefficient of the interface members can influence the tissue delivery capacity and are designed to maximize the desired tissue delivery efficiency .

Figures 15-18 illustrate alternative embodiments of the catheters of Figures 1-14. A catheter 2A is shown wherein the same or similar reference numerals of the catheter 2A refer to the same or similar structure of the catheter 2 and all discussion of the same or similar features of the catheter 2 is made in a different If there is no mention, the same applies here. In the first embodiment shown in Figs. 15 and 16, the inner cutter drive shaft 6c of the catheter 2A is hollow and has a guide wire lumen 37 extending to the full length of the inner cutter drive shaft. The guide wire lumen 39 of the rotating tissue perforator 7 is arranged to be aligned with the guide wire lumen 37 of the inner cutter drive shaft 6c. The guide wire lumens of the inner cutter drive shaft and the rotating tissue puncture extend from the proximal end to the distal end of the catheter 2A so that the catheter can be used as an over-the-wire catheter. Figure 15 shows the catheter 2A with the guide wire GW.

Figures 17 and 18 illustrate an embodiment of the present invention including a quick-change catheter. A catheter 2B is shown wherein the same or similar reference numerals of the catheter 2B refer to the same or similar structure of the catheter 2 and all discussion of the same or similar features of the catheter 2 If there is no mention, the same applies here. The catheter 2B includes a side mounting tubular portion 55 that defines a relatively short guide wire lumen for receiving a guide wire GW. The length of the side-mounting tubular portion 55 may range from 1 to 30 cm, depending on the application.

An exemplary method of using the catheters of FIGS. 1-18 is shown in FIGS. 19A-19C, and this method is described. The guide wire is introduced percutaneously into the patient's body and advanced to the region of interest of the patient's blood vessel (V). If the treatment site is a CTO, as shown in Fig. 19A, the guide wire may not cross the lesion. 19A shows the lumen completely closed when the guide wire GW advances to the proximal side of the occluded material. The catheter 2 was advanced over the guide wire to a very close position of the occlusion. In Figure 19 (a), the guide wire is not shown because it has entered the catheter. During the advancement, the distal cutting element and the rotating tissue perforator are stationary and can be covered with the sheath 5. Conventional prior art catheters have forced lesions to penetrate, or to give up treatment for other forms of treatment. According to the catheter 2 (and other catheters disclosed herein), by activating one or both of the outer cutter driver 10 and the inner cutter driver 11 to rotate the inner and outer cutter drive shafts, You can cross safely. The rotation of the inner cutter drive shaft causes rotation of the rotating tissue perforator 7. The rotating tissue perforator 7 also punctures the calcified material so that the catheter can slowly advance through the lesion and the distal cutting element 4 is also in contact with the treatment site to remove from the lesion as shown in Figures 19b and 19c The material is cut. In some applications, only the inner cutter driver may be coupled to rotate the rotating tissue perforator to initially puncture the entire occlusion, and in other applications, only the outer cutter driver may be initially engaged to rotate the distal cutting element It is noted that it may be necessary to provide The cutting material is introduced into the collection chamber through a cutting element flute and a perforator flute. The force applied to the catheter 2 against the material M causes a pressure which helps to force the cut material to pass through the flutes 23, This cleavage procedure can be repeated by advancing and retracting the catheter across the treatment site until a sufficient amount of material has been removed. At any time during the procedure, debris can be aspirated through the catheter, or fluid can be introduced into the blood vessel through the catheter via the annular space between the inner and outer drive shafts. Also, at any time during the course of the procedure, the guide wire can be removed, the debris can be aspirated through the lumen of the guide wire, or fluid can be introduced into the blood vessel through the guide wire lumen. The catheter 2B shown in Figs. 17 and 18 can be used as described above, except that it is advanced to the treatment site on the guide wire disposed in the guide wire lumen formed by the side mount tubular portion 55. Fig.

An alternative catheter embodiment is shown in Figures 20-22. A catheter 2C is shown wherein the same or similar reference numerals of the catheter 2C refer to the same or similar structures of the catheter 2 and all discussion of the same or similar features of the catheter 2 If there is no mention, the same applies here. Compared to the catheter 2, the inner cutter drive shaft 6d does not have a separate rotating tissue perforator. The inner cutter drive shaft 6d is formed with a drill bit tip 8 capable of drilling an obstruction in the lumen. A helical channel 18 is additionally formed in the inner cutter drive shaft 6d and this helical channel is formed by cutting the material cut by the puncturer tip 8 and the distal cutting element 44 into the distal cutting element 44 To the tissue chamber 12 via the helical flute 47. [ The distal cutting element 44 includes a central opening 46 having an inner periphery slightly larger than the outer periphery of the inner cutter drive shaft 6d. As the inner cutter drive shaft 6d rotates, the material is carried from the distal end of the catheter through the drive shaft bushing 19 to the collection chamber 12, due to the groove of the helical channel 18. The inner cutter drive shaft has an attached drive shaft bushing 19 that is formed on the surface of the inner cutter drive shaft 6d or can be welded or brazed etc. This drive shaft bushing is attached to the outer periphery of the drive shaft bushing 19 And functions as a bearing that limits the movement of the inner cutter drive shaft 6d in the distal direction while permitting rotation of the inner drive shaft. The cutting element flutes 47 guide the cutting material or tissue inward toward the inner cutter so that the tissue can be directed through the groove 18 at the distal end of the catheter into the tissue collection chamber of the catheter 2. In some embodiments, the distal cutting element 44 may have a cup-shaped surface 48 that is smooth and continuous without through holes, teeth, pins, or other features that impair the planarity of the surface 48. In some embodiments, Lt; / RTI >surface; In other embodiments, the cup-shaped surface may have a limited amount of teeth, fins, or other features. The outer cutter drive shaft 3a can be connected to the distal cutting element 44 at the cutting element portion 45 by welding, brazing, brazing or adhesive bonding. This connection allows rotation of the cutting element 44 as the outer cutter drive shaft 3a rotates.

An embodiment of an alternative catheter is shown in Figures 23-25. A catheter 2D is shown wherein the same or similar reference numerals of the catheter 2D refer to the same or similar structures of the catheter 2 and all discussion of the same or similar features of the catheter 2 If there is no mention, the same applies here. The catheter 2D is similar to the catheter 2C except that the bushing 19 is disposed in a proximal position and housed within an annular slot formed in the inner wall surface of the outer cutter drive shaft. The bushing 19 is seated in the slot in a manner that allows rotation of the inner cutter drive shaft but inhibits both the distal or proximal movement of the inner cutter drive shaft relative to the outer cutter drive shaft. The bushing 19 is attached to the inner cutter drive shaft. The distal outer housing 59 and the proximal outer housing 60 control the longitudinal position of the inner drive shaft in both the proximal and distal directions by effectively restraining the bushing 19 therebetween and allow assembly of the components. In this embodiment, the severed tissue must pass under the open lumen of the assembly between the inner drive shaft and the bushing 19. In this embodiment, the outer drive shaft is connected to a cutting element 54 having a tooth 56 and a pin 57.

The foregoing description and drawings are provided for the purpose of illustrating embodiments of the present invention and are not intended to limit the scope of the present invention in any way. It will be apparent to those skilled in the art that various changes and modifications may be made without departing from the spirit or scope of the invention. Accordingly, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. Also, while the choice of materials and configurations has been described above with regard to specific embodiments, those of ordinary skill in the art will appreciate that the materials and configurations described are applicable throughout the embodiments.

Claims (20)

A substance removal device for cutting a substance from the lumen of a blood vessel,
A first drive shaft having a proximal end and a distal end and configured to rotate in a first direction;
A second drive shaft having a proximal end and a distal end and configured to rotate in a second direction;
A first cutting element at a distal end of a first drive shaft configured to rotate about a first axis of rotation, the first cutting element having a distal end, an opening extending proximally through a distal end of the first cutting element, A first cutting element having an annular cutting edge at a distal end of the first cutting element for cutting; And
A second cutting element at a distal end of a second drive shaft configured to rotate about a second axis of rotation and wherein the second cutting element is tapered upwardly toward the second axis of rotation to a distal tip of the second cutting element The second cutting element having a conical distal portion, the second cutting element being configured to receive the opening of the first cutting element and to puncture the material of the vessel lumen,
/ RTI > The method according to claim 1,
Further comprising a driver coupled to the first drive shaft and the second drive shaft and configured to rotate the first drive shaft in a first direction and to rotate the second drive shaft in a second direction, Device. 3. The method of claim 2,
Wherein the first direction is opposite to the second direction. 3. The method of claim 2,
Wherein the actuator is configured to rotate the first drive shaft at a first speed and to rotate the second drive shaft at a second speed, wherein the first speed is different from the second speed. The method according to claim 1,
Wherein the first drive shaft is tubular and includes an inner surface defining a lumen and the second drive shaft is at least partially received within the lumen of the first drive shaft. 6. The method of claim 5,
Wherein the second drive shaft has an outer surface and a material receiving chamber is formed between an outer surface of the second drive shaft and an inner surface of the first drive shaft. The method according to claim 6,
Wherein at least one of the outer surface of the second drive shaft and the inner surface of the first drive shaft includes at least one raised material transfer element, the at least one raised material transfer element is configured to move the material cut from the lumen of the vessel in a proximal direction Wherein the device is configured to move the substrate. 8. The method of claim 7,
Wherein the at least one raised material transfer element is disposed in a spiral pattern. 5. The method of claim 4,
Wherein the first direction is the same as the second direction. 9. The method of claim 8,
Wherein the at least one raised material transfer element is a helical rib. The method according to claim 1,
Further comprising a tubular sheath having a lumen,
Wherein the first and second cutting elements are configured to have a first state in which the first and second cutting elements are received within the lumen of the tubular sheath and a second state in which the first and second cutting elements are at least partially And a second state in which the second state is exposed. 3. The method of claim 2,
Wherein the actuator comprises a simple drive motor. delete delete delete delete delete delete delete delete

Images